Now Hiring: Advanced Manufacturing Engineer
We are seeking an experienced Advanced Manufacturing Engineer to support the implementation of design changes for medical device electronic hardware.
This role will partner closely with a Lead Manufacturing Engineer and provide technical support across process validation, test method validation, manufacturing systems, and production support.
Top 3 Required Technical Skills
- Process Validation
- PLM & ERP/MRP Systems in Manufacturing Engineering
Key Responsibilities
- Support the development and validation of new manufacturing processes.
- Develop and execute process validation plans, including IQ/OQ/PQ.
- Perform statistical analysis to evaluate process repeatability and capability.
- Lead/support Test Method Validation and Gauge R&R activities.
- Support software validation for hardware test systems.
- Manage product BOM configurations within PLM systems.
- Integrate new components and BOM information into ERP/MRP systems.
- Create and maintain manufacturing documentation, including:
- Engineering protocols and reports
- Process risk documentation / PFMEA
- Manufacturing instructions
- Statistical analysis
- Generate documentation and BOM structures to support service depots.
- Provide engineering support to manufacturing operations.
- Investigate and resolve quality issues arising on the production floor.
- Collaborate with cross-functional teams during design changes and manufacturing implementation.
Required Qualifications
- Bachelor’s degree in engineering or another technical discipline.
- Minimum 4 years of relevant experience; 5+ years preferred.
- Experience with process validation and manufacturing engineering.
- Experience with Test Method Validation / Gauge R&R.
- Experience using PLM and ERP/MRP systems in a manufacturing environment.
Nice-to-Have Qualifications
- Master’s degree in a technical discipline.
- Medical device manufacturing experience.
- Experience in an electronics manufacturing environment.
- Knowledge of PFMEA, statistical analysis, and equipment/process qualification.